Lens delivery system

ABSTRACT

Delivery devices for delivering an ophthalmic device into an eye. In some embodiments the delivery devices are adapted to deliver an intraocular lens into an eye.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/637,171, filed Mar. 3, 2015, which is a continuation of U.S.application Ser. No. 13/835,876, filed Mar. 15, 2013, now U.S. Pat. No.8,968,396, which application is a continuation-in-part of U.S.application Ser. No. 12/178,565, filed Jul. 23, 2008, now U.S. Pat. No.8,956,408, which claims priority to U.S. Provisional Application No.60/951,439, filed Jul. 23, 2007, the disclosures of which areincorporated by reference herein.

Said application Ser. No. 13/835,876 also claims the benefit of U.S.Provisional Application No. 61/613,929, filed Mar. 21, 2012, thedisclosure of which is incorporated by reference herein.

This application is related to and incorporates by reference herein thedisclosures of the following U.S. patent applications: U.S. applicationSer. No. 13/180,427, filed Jul. 11, 2011, and U.S. application Ser. No.13/427,617, filed Mar. 22, 2012.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

Intraocular implants such as an intraocular lens (“IOL”) can bedelivered into the eye through a small incision made in the cornea.Delivery devices have been developed to aid in the delivery andinsertion of such implants into the eye.

A corneal or scleral incision allows access to the eye and the smallerthe incision the less damage will be done and the less time will beneeded for the incision to heal. In addition, the intraocular lens ispreferably not damaged during delivery, or at most, minimally damagedsuch that it will not affect the functionality of the intraocular lens.

Depending on the physical characteristics of the intraocular lens (e.g.,shape, size, etc.), the shape and/or configuration of the intraocularlens may need to be reduced in size or altered during the deliveryprocess to enable the intraocular lens to be inserted through a smallincision. The reduction in size or adjustment of the configuration/shapeof the lens allows for a smaller delivery profile.

A delivery device is therefore needed that will reduce the deliveryprofile of the intraocular lens such that it can be delivered into theeye through a small incision. Additionally, the delivery deviceminimizes and preferably eliminates damage done to the lens during thedelivery process, including the loading of the intraocular lens into thedelivery device.

SUMMARY

One aspect of the invention is a method of hydraulically loading anintraocular lens into a delivery system. The method includes positioningan intraocular lens within a compression chamber and adjacent a deliverydevice, wherein the compression chamber and the delivery device are influid communication. The method includes flowing a fluid through thecompression chamber and into the delivery device, wherein flowing thefluid through the compression chamber comprises loading the intraocularlens into the delivery device.

In some embodiments loading the intraocular lens into the deliverydevice comprises compressing the intraocular lens from an unstressedexpanded configuration to a stressed delivery configuration. Compressingthe intraocular lens can increase the length of the intraocular lens.The intraocular lens can comprise a fluid therein, and whereincompressing the intraocular lens comprises redistributing the fluid withthe intraocular lens.

In some embodiments the intraocular lens comprises an optic portion, afirst haptic, and a second haptic, and wherein positioning theintraocular lens within the compression chamber comprises positioningthe first haptic distal to the optic portion.

One aspect of the invention is a hydraulic loading system for loading anophthalmic device into a delivery device. The system includes acompression chamber with a tapered inner surface, wherein thecompression chamber contains a fluid therein. The system includes adelivery device comprising an elongate loading element wherein theelongate loading element and the compression chamber are in fluidcommunication. The system includes an ophthalmic device disposed in afirst configuration within the compression chamber. The system alsoincludes a loading device adapted to cause the fluid to flow through thecompression chamber and into the elongate loading element, therebyloading the ophthalmic device into the elongate loading element. In someembodiments the fluid contains a lubricant.

In some embodiments the ophthalmic device is an intraocular lens. Insome embodiments the loading device comprises a plunger to direct thefluid through the compression chamber and into the elongate loadingelement.

One aspect of the invention is a method of loading an intraocular lensinto a delivery device. The method comprises providing a delivery devicecomprising an everting tube comprising an inner tube portion and anouter tube portion, wherein the everting tube is coupled to a firstactuation element. The method includes loading the intraocular lens intoan end of the everting tube by actuating the first actuation element,wherein actuating the first actuation element everts a section of theouter tube portion into the inner tube portion about the end of theeverting tube.

In some embodiments loading the intraocular lens into an end of theeverting tube comprises compressing the intraocular lens within theinner tube portion. In some embodiments loading the intraocular lensinto an end of the everting tube comprises loading a first haptic intothe end of the everting tube before loading an optic portion of theintraocular lens. Loading the first haptic into the end of the evertingtube can include forcing a volume of fluid from the first haptic intothe optic portion.

In some embodiments loading the intraocular lens into an end of thedelivery tube comprises engaging the intraocular lens and the inner tubeportion, wherein the inner tube portion compresses the intraocular lensas the everting tube everts. In some embodiments actuating the firstelement moves the first actuation element in a proximal direction or adistal direction.

One aspect of the invention is a method of loading an intraocular lensinto a delivery device. The method includes compressing an intraocularlens from a first configuration to a second configuration within a firstportion of the delivery device, wherein compressing the intraocular lenscomprises applying a compressive force to the intraocular lens in adirection generally orthogonal to a longitudinal axis of the deliverydevice. The method also includes actuating a second portion of thedelivery device to move the second portion of the delivery devicerelative to the first portion of the delivery device in a directiongenerally parallel to the longitudinal axis of the delivery device,wherein actuating the second portion relative to the first portion loadsthe intraocular lens into the delivery device.

In some embodiments applying a compressive force to the intraocular lenscomprises applying the compressive force indirectly to the first portionof the intraocular lens. In some embodiments applying a compressiveforce to the intraocular lens comprises applying the compressive forcedirectly to a third portion of the intraocular lens, wherein the methodfurther comprises engaging the third portion and the first portion.

In some embodiments the first portion and the second portion slidinglyengage one another, and wherein actuating a second portion comprisessliding the second portion over the first portion. The delivery devicecan include a third portion engaging an outer surface of the firstportion, and wherein sliding the second portion over the first portiondisplaces the third portion from the first portion.

In some embodiments compressing the intraocular lens within a firstportion of the delivery device comprises moving a first half of thefirst portion closer to a second half of the first portion.

One aspect of the invention is a loading system for loading anintraocular lens into a delivery device. The system comprises an outerloading tube adapted to be inserted through an incision in the eye andan inner sleeve slidingly engaged with the outer loading tube andadapted to be disposed within the outer loading tube. The inner sleeveis adapted to engage an intraocular lens therein. The system includes acompressing member disposed adjacent an outer surface of the innersleeve.

In some embodiments the inner sleeve comprises a first sleeve elementand a second sleeve element, and wherein the first sleeve element andthe second sleeve element are disposed apart from one another in a firstconfiguration and are moved towards one another in a deliveryconfiguration, thereby compressing the intraocular lens.

In some embodiments the compressing member comprises a first compressingelement and a second compressing element, and the first compressingelement engages an outer surface of the first sleeve element and thesecond compressing element engages an outer surface of the second sleeveelement. The first compressing element and the second compressingelement can be disposed apart from one another in a first configurationand are moved towards one another in a second configuration. The outerloading tube can be adapted to be actuated to displace the compressingmember.

In some embodiments the outer loading tube is coupled to a loading tubeactuator and the inner sleeve is coupled to an inner sleeve actuator,and wherein actuation of either the loading tube actuator or the innersleeve actuator moves the outer loading tube relative to the innersleeve.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A, 1B and 1C illustrate an exemplary fluid-driven accommodatingintraocular lens.

FIGS. 2 and 3 show an exemplary delivery device.

FIGS. 4, 5, 6, 7 and 8 illustrate an exemplary embodiment of an evertingtube with a slit therein.

FIGS. 9 and 10 illustrate an exemplary delivery device incorporating aneverting tube.

FIGS. 11A, 11B, 11C and 11D show an exemplary delivery deviceincorporating an everting tube.

FIGS. 12A, 12B and 12C illustrate the loading of an exemplaryintraocular lens in a delivery device.

FIGS. 13A, 13B and 13C illustrate the deploying of an exemplaryintraocular lens from a delivery device.

FIG. 14 illustrates an exemplary delivery device relative to anexemplary intraocular lens.

FIGS. 15, 16 and 17 illustrate an alternative delivery device.

FIGS. 18A, 18B, 18C, 18D and 18E illustrate an alternative deliverydevice.

FIG. 19 shows an exemplary hydraulic loading system for loading anintraocular lens.

FIG. 20 illustrates an alternative hydraulic loading system for loadingan intraocular lens.

FIG. 21 illustrates an exemplary peristaltic loading concept.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates generally to delivery devices fordelivering an intraocular implant, such as an IOL, through an incisionin an eye. The delivery devices generally compress and increase thelength of the IOL (or at least portions of the IOL) into a deliveryconfiguration such that it can be delivered through a small incision,relative to the size of the IOL, into the eye. In addition, the deliverydevices minimizes shear and tensile forces to the IOL during thedelivery process to minimize and preferably eliminate damage to the IOL.

The IOLs described herein are accommodating IOLs implanted within a lenscapsule after the native lens has been removed from the eye. Inparticular, the IOLs contain flowable media such as a fluid that is, inresponse to ciliary muscle movement, moved in the IOL to change thepower of the IOL. Such exemplary IOLs are described more fully in U.S.Provisional Application No. 60/433,046, filed Dec. 12, 2002; U.S. Pat.Nos. 7,122,053; 7,261,737; 7,247,168; and 7,217,288; U.S. patentapplication Ser. No. 11/642,388, filed Dec. 19, 2006, now U.S. Pat. No.8,361,145; and U.S. patent application Ser. No. 11/646,913, filed Dec.27, 2006, now U.S. Pat. No. 7,637,947, the complete disclosures of whichare hereby incorporated herein by reference. Is it also contemplatedthat the delivery devices described herein can, however, be used todeliver other types of accommodating IOLs (e.g., non fluid-drivenaccommodating IOLs), non-accommodating IOLs, and even other types ofintraocular implants. In addition, it is contemplated that the deliverydevices can be used to deliver the IOL or other ophthalmic device toportions of the eye other than within the lens capsule, such as theanterior chamber or to the posterior chamber after a lens capsule hasbeen removed.

The delivery devices reduce the delivery profile of the IOL bycompressing the IOL, or portions of the IOL, from an expandedconfiguration to a delivery configuration. In some embodiments the IOLassumes a generally circular shape before being loaded of the deliverydevice, but is compressed into a lengthened generally cylindrical shapeby the delivery device. One advantage of the delivery devices is thatthey minimize the amount and/or types of forces acting on the IOL duringthe delivery procedure (including the loading and deployment), which canhelp minimize the amount of damage to the IOL during delivery. This canbe advantageous for delicate IOLs (comprised, for example, of polyermicmaterials) and/or IOLs which comprise a plurality of interconnectedcomponents, the mating or bonded elements of which can be damaged bycertain types of forces acting on the IOL during a loading anddeployment procedure.

In preferred embodiments, the delivery devices minimize shear andtensile forces on the IOL during the delivery process, and insteadreshape the IOL under compression.

FIGS. 1A-1C illustrate an exemplary fluid-driven accommodating IOL 210that can be delivered within the lens capsule with the delivery devicesdescribed herein. IOL 210 includes a non-option peripheral portion whichincludes haptics 212 and 214. IOL 10 also includes an option portionwhich includes anterior element 216, intermediate layer 218, andposterior element, or substrate, 222. Intermediate layer 218 includesactuator 220. Haptics 212 and 214 define interior volumes 224 which arein fluid communication with active channel 226 defined by posteriorelement 222 and intermediate layer 218. The haptics engage the capsularbag such that zonule relaxation and tightening causes deformation of thehaptics, which distributes a fluid disposed in the haptics and activechannel between the haptics and the active channel. When fluid isdirected from the haptics to the active channel, the pressure increasein the active channel deflects actuator 220 in the anterior direction,causing the curvature of anterior element 216 to become steeper. Thisincreases the power of the IOL. This process is described in more detailin any of the exemplary patent applications and patents listed above.

FIG. 2 illustrates an exemplary embodiment of delivery device 2 and IOL100. IOL 100 comprises optic portion 102 and haptics 104 (see FIG. 3)positioned within the delivery device in an unstressed, or expanded,configuration. Delivery device 2 includes inserter body 4, pull block 6,and belts 8. The pull block is connected to the belts on the beltportions that are on the exterior surfaces and bottom surface of theinserter body (bottom not shown), but is not connected to the belts onthe inside of the inserter body. Movement of the pull block in either ofthe direction of arrows D and P moves the portion of the belts on theinside of the inserter body to move in the direction generally oppositethe direction of movement of the pull block. For example, when pullblock 6 is moved in the proximal, or P direction, the belt portions onthe interior of the body move generally in the D direction. The beltsact generally as conveyor belts to move the IOL the pull block isactuated.

In use, when the pull block is pulled in the proximal direction (thedirection of arrow P in FIG. 2), this causes the portion of the belts onthe inside of the inserter body to move in the general distal direction(the direction of arrow D) along the interior surfaces of the inserterbody. The belts on the outside and bottom of the inserter body move inthe proximal direction as well. As the portion of the belts on theinside of the inserter body move distally, they eventually move arounddistal end 5 of the inserter body to the outside of the inserter body.

Similarly, when the pull block is pushed distally, or in direction D,the portion of the belts on the outside and bottom of the inserter bodymove distally and the portion of the belts on the inside of the inserterbody move proximally. This causes the IOL in the inside of the body tomove in the proximal direction.

The delivery device is configured so that only the belts and not theinserter body (or as little of the inserter body as possible) engage theIOL. Because the IOL does not make contact with the inserter body (orany other parts of the delivery device that may be added), the inserterbody does not apply tensile force or shear forces/stress on the IOL asthe IOL is moved by the belts. In addition, because the belts move withthe IOL, the amount of shear and tensile forces applied to the IOL bythe belts are minimized. As shown in FIG. 2, there is an opening orspace 10 formed in the bottom surface of the inserter body. The openingin the inserter body is created to avoid contact between the inserterbody and the IOL to help minimize unwanted forces on the IOL.

To deliver the IOL into the eye, the IOL is positioned in the interiorof the inserter body, making contact with substantially only the belts.The IOL is positioned in an expanded configuration so it is just barelymaking contact with the belts (as shown in FIG. 2). The pull block isactuated in the proximal direction and the IOL is moved in the distaldirection towards the distal end 5 of the device. Because of the reducedwidth of the distal end of the device compared to proximal end 7, theIOL is compressed as it moves distally and then passes out of distal end5. It is delivered from the distal end of the device into the eye, whereit expands after being released from the delivery device.

When compressing a closed-system fluid-filled IOL (as is shown in 1A-1Cand in FIG. 2) in the conveyor system, the portion of the IOL nearest todistal end 5 of inserter body 4 will begin to compress before the restof the IOL. As the distal end of the IOL begins to compress, fluidcontained within the IOL will generally be squeezed or forced into moreproximally positioned portions of the IOL. In addition, the firstportion of the IOL to be deployed from the delivery device will begin toexpand, and while more proximal portions of the IOL continue to becompressed, some fluid will begin to be squeezed distally into the nowfree and expanding distal portion of the IOL.

It may therefore be advantageous to orient the IOL in the inserter bodyprior to compression such that fluid will be distributed throughout theIOL in a predictable manner to enable compression and minimize damage tothe IOL. For example, FIG. 3 shows distal end 5 of the inserter body inmore detail. The IOL is positioned in the inserter body so that aleading (or distal) haptic 12 begins to be deployed first from theinserter body. When the leading haptic begins to be released from theinserter body, the leading haptic can receive fluid that is squeezedfrom the optic portion and/or trailing haptic 14.

This embodiment may require high tensile forces on the belts, so apulling mechanism would preferably utilize features designed to increasemechanical advantage. Levers, screws, and/or ratchets could be used togive a user the control as well as the required force.

The inserter body is generally a rigid structure with a general taperedshape with the width decreasing towards the distal end to compress theIOL as it is moved in the distal direction. In some embodiments thedistal end of the inserter body is less than about 50% of the width ofthe proximal end. This is not intended to be a limitation and may beless than about 40%, about 30%, about 20%, about 10%, or less, than thewidth of the proximal section. While the embodiment shown only includesa bottom surface, the inserter body could also have a top surface (witha similar space as in the bottom surface to avoid sliding). If theinserter body did have a top surface, a fourth belt could then also beincluded in the device.

The pull block and belts can be made of a relatively rigid material suchas Mylar or an elastomeric material such as a silicone.

While three belts are shown in this embodiment there may be more, suchas 4, or fewer in the delivery device.

FIG. 4 illustrates a second embodiment of a delivery device. In thisembodiment the delivery device comprises an everting tube 30 thatincludes at least one slit or cut 32 along at least a portion of thelength of the tube. The term everting as used herein generally meansthat at least one section of the tube is adapted to roll back or foldback onto the tube, like a pair of socks or the cuff on a pair of pants.In some embodiments, however, the everting tube does not have a slit.

Everting as used herein can refer both to the step when the innersurface of the tube rolls outward and back and becomes an outer surfaceof the tube, or when an outer surface of the tube rolls inward andbecomes an inner surface.

FIG. 4 shows everting tube 30 in a non-everted state (no section of tubeis everted, or rolled back). Slit 32 is shown running parallel to thelongitudinal axis LA of the tube 30.

FIG. 5 is a cross sectional view of the tube with a distal portion 34everted, however the portion of the tube including slit 32 has not yetbeen everted.

FIG. 6 shows a perspective view of an exemplary everting tube 30 as theportion of the tube including the slit has begun to evert. The slit inthe tube causes the portion of the tube circumferentially surroundingthe slit to “blossom” as the distal end of the slit reaches the distalend of the tube and as the portion of the tube circumferentiallysurrounding the slit begins, and continues, to evert. FIG. 7 shows theslit continuing to blossom. FIG. 8 is a distal end view of the slitblossomed. Once the slit portion of the tube is fully everted, theremainder of the tube continues to evert in the same manner as did theportion of tube disposed proximally to the slit. It is in this mannerthat the slit in the tube allows for a greater expansion or opening ofthe tube as it is everted.

In one embodiment of the everting tube concept as shown in FIG. 9, theeverting tube is coupled to a syringe-like device 40. Device 40 includesan outer body 42 comprising an inner bore or channel through which innerbody 44 passes. Inner body 44 includes handle 46 at its proximal end.The proximal end 50 of everting tube 30 is coupled to distal portion 45of inner body 44 and distal end 52 of the everting tube 30 is coupled toouter body 42. When inner body 44 is actuated in the distal direction(e.g., by pushing handle 46 distally), inner body 44 moves distallyrelative to outer body 42. Because the proximal end of the everting tubeis coupled to distal portion 45 of the inner tube, this movement alsomoves the proximal portion of the everting tube in the distal direction.Distal end 52 of the everting tube remains coupled to outer body 42 andthus does not move. Similarly, when the inner body is moved or pulledproximally, such as by pulling on the handle in the proximal direction(or otherwise actuating inner body 44), inner body 44 moves proximallyrelative to outer body 42 and therefore so does the proximal end of theeverting tube. It is noted that it is the relative movement of the innerand outer bodies that controls the movement (and thus the everting) ofthe everting tube, and the outer body can similarly be advanced in thedistal direction or retracted in the proximal direction over the innerbody to cause the relative movement.

In addition the inner and outer bodies may be disposed within an outersheath such that the user of the delivery device would not see the innerand outer bodies. The inner and outer bodies could also be coupled to anactuator such as a control knob which a user could use to carefullycontrol the advancement of the inner body relative to the outer body orthe retraction of the outer body relative to the inner body. This couldgive the user precise control over the delivery of the IOL.

To deliver an IOL into the eye, an IOL is first loaded into the distalend of the delivery device shown in FIG. 9 as follows. Handle 46 isadvanced distally (or a knob is rotated, or other actuator to controlthe relative movement of the inner and outer bodies) as shown in FIG. 9such that a portion of the everting tube is disposed outside and distalto outer body 42. The slit in the everting tube is exposed, or outsideof the outer body, and has “bloomed.” The IOL is placed into theblooming opening and the handle is then actuated in the proximaldirection, or the outer body is advanced in the distal direction, orboth. As the inner layer of the everting tube moves in the proximaldirection, causing more of the outer layer of the tube to roll inwardand become part of the inner layer of the tube, the slit is retractedwithin the outer layer of the tube. The slit is thereby forced closedand the device is compressed in the tube via the hoop forces on theclosed, or intact, portion of the tube.

Because the tube is everting inward and moving with the IOL (similar tothe belts in the embodiment shown in FIGS. 2 and 3), the amount of shearand tensile forces on the IOL are minimized. Substantially all of thesliding (and accompanying shear forces) occurs between the two layers ofthe everting tube, so there is no (or very little) sliding between theeverting tube and the IOL. In some embodiments a lubricant is applied tothe everting tube to minimize shear and forces.

As the handle continues to be pulled in the proximal direction, the IOLcontinues to be loaded into the outer body as the IOL moves furtherproximally into the channel. In this embodiment, the compression isaccomplished as the hoop forces force the IOL to be compressed as it isdrawn into the everting tube.

FIG. 10 shows a cross sectional view of an exemplary IOL 100 with aportion of the IOL loaded into the delivery device (and within theeverting tube), as described by the loading process above. The exemplaryIOL 100 is a soft, flexible, accommodating IOL which includes an opticportion 102 and a peripheral portion comprising haptics 12 and 14 influid communication with the optic portion. The IOL comprises fluidwhich is transferred between the haptics and optic portion toaccommodate the IOL in response to ciliary muscle movement.

When compressed into the delivery configuration, the length of IOL 100increases (as is shown in FIG. 10) while the IOL narrows. Whencompressed, the fluid within the IOL is squeezed from the portion of theIOL loaded first. As shown in FIG. 10, proximal, or trailing, haptic 14is loaded first, which squeezes the fluid from the proximal haptic intothe optic portion (and likely into distal haptic 12 as well). As theoptic portion is loaded into the delivery device (e.g., as the handlecontinues to be pulled proximally), the optic portion is compressed bythe everting tube and the fluid in the optic portion is squeezed intothe distal haptic 12.

FIG. 10 shows the IOL in the loaded, or delivery, configuration. Distalhaptic 12 is external to the delivery device and contains a largervolume of fluid that it contains when the IOL is in an expandedconfiguration. Similarly, optic portion 102 and trailing haptic 14contain less fluid than they do when in an expanded configuration. Inthis delivery configuration, the IOL has been partially compressed andelongated, and much of the fluid has been squeezed into the distal, orleading, haptic.

To deploy the IOL into the eye (e.g., into the lens capsule of which thenative lens has been removed), the distal, or leading, haptic is pushedthrough the corneal incision and into the capsule. Then inner body 42 ispushed distally (or the outer body is pulled proximally, or both), whichcauses the everting tube and the loaded IOL to move distally together,deploying the IOL from the delivery device and into the eye by squeezingout through the blooming slit portion of the everting tube. As the opticportion of the IOL begins to be released from the outer body, the fluidmoves from the distal haptic to the optic portion, causing the opticportion to expand in volume. Then, as the proximal haptic is releasedfrom the delivery device it begins to refill with fluid and increases involume. Once the IOL has completely been deployed outside of thedelivery device (and into the capsule), the IOL has generally returnedto its pre-loaded, generally expanded, configuration (although the shapeof the IOL may be slightly altered after implantation due to forcesacting on the IOL by the lens capsule). The delivery device is thenremoved from the eye.

FIGS. 11A-11D show an alternative embodiment of delivery device 70comprising outer body 72 and inner body 74 with knob 76. To load theIOL, knob 76 is rotated which actuates inner body 74 in the proximaldirection and/or actuates the outer body in the distal direction. Todeploy the IOL, the knob 76 is rotated which actuates the inner body inthe distal direction and/or actuates the outer body 72 in the proximaldirection. Sheath 73 covers outer body 72 and provides the surgeon astable handle with which to work. FIG. 11D shows a close-up perspectiveview of distal end 77 of everting tube 78.

In the embodiments shown in FIGS. 11A-11D, distal end 77 of the evertingtube can be adapted such that it does not move relative to the eyeduring the implantation procedure. The tube will evert (the inner tubebecome outer tube, or the outer tube becomes inner tube), however thedistal end remains substantially fixed in space. This is importantbecause the user does not have to worry about distal end 77 contactingand disrupting the eye during the procedure. The user also does not haveto worry about moving the distal end of the delivery system relative tothe eye during the deployment procedure.

FIGS. 12A-12C show the loading of IOL 80 into delivery device 70 asdescribed above. IOL 80 comprises trailing haptic 82, optic portion 84,and leading haptic 86. Delivery of the IOL into an eye occurs in thereverse order of the steps shown in FIGS. 12A-12C.

FIGS. 13A-13C show deployment of IOL from delivery device 70. FIG. 13Ashows a leading haptic extending from the distal end of the evertingtube. FIG. 13B shows the optic portion emerging, and FIG. 13C shows thetrailing haptic almost completely deployed. FIG. 14 illustrates the sizeof delivery device 70 next to IOL 80.

In some embodiments the everting tube is a thin, tough, generallystretchy material that is adapted to be everted. To evert a tube it isgenerally preferred to be somewhat stretchy and very thin relative tothe inner diameter of the tube. A composite material with relativelydifferent axial and circumferential stiffnesses may also be used. Forinstance, a tube can contain fibers running along the longitudinal axisof the tube that serve to stiffen the tube in the axial direction whilemaintaining the elastic properties in the circumferential direction.Alternatively, the everting tube can be formed by being drawn to provideextra stiffness along its length.

While the embodiments above show and describe one slit in the evertingtube, the delivery device may have more than one slit, such as 2, 3, 4,5, or more slits. The slits may be positioned around and along thelength of the tube in any orientation that helps minimize the shear andtensile forces on the IOL during loading or deployment. In someembodiments the everting tube has no slits.

A variety of actuation mechanisms may be used to deliver the device. Forexample without limitation, a knob, a trigger, or a lever mounted on agrip may be used as alternatives to the syringe design.

FIG. 15 illustrates an alternative delivery device 60 which comprisesbody 62, inserter 64, and advancement mechanism, or actuator, 66, whichis coupled to inserter 64. Inserter 64 is a sheet that is rolled upalong its length wherein one edge of the inserter overlaps the other, asshown in FIG. 16. The proximal end (not shown) of inserter 64 is coupledto the distal end (not shown) of advancement mechanism 66. Asadvancement mechanism 66 is actuated in the proximal direction, inserter64 is withdrawn into body 62. Body 62 generally compresses inserter 64when inserter 64 is withdrawn in to body 62. This causes the diameter ofinserter 64 to decrease and the sheet forms a tighter roll or curl.

FIG. 16 is a distal end view of the inserter and FIG. 17 shows aperspective view of a distal end of body 62 with inserter 64 withdrawninto body 62.

To load the IOL into the delivery device 60, the advancement mechanismis pushed distally to deploy inserter 64 from the distal end of body 62(as shown in FIG. 15). The distal end of the inserter body will assume amore open (i.e., the curl is not as tight), or first, configuration,allowing the IOL to be positioned in the distal end of the inserter.After placement of the IOL in the distal opening of the inserter, theadvancement mechanism is pulled proximally (or body 62 is pusheddistally). This pulls the inserter into body 62 whereby the body 62exerts a compressive force on the inserter, causing it to fold moretightly into itself. The inserter thus applies a compressive force tothe IOL. As in the other embodiments above, because the IOL movesproximally with the inserter, it is compressed within the inserter. Theinserter and IOL move together and therefore shear and tensile forcesacting on the IOL are minimized.

Once loaded into the delivery device, the IOL can then be insertedthrough the wound as described above.

Once body 62 has been advanced into the wound advancement mechanism 66is advanced distally, which begins to deploy the folded inserter fromthe body. The IOL moves with the inserter as it is advanced out of body62. As the inserter is pushed from body 62, it begins to unroll, oropen, allowing the optic and trailing haptic to begin to expand andagain fill with fluid that had been squeezed into the leading hapticwhen the IOL was in the loaded delivery configuration.

This embodiment may be used with an additional secondary advancementmechanism to further advance the IOL from the rolled inserter. Forexample, a plunger-like device could be disposed within an internal boreor channel in the advancement mechanism. The plunger-like device couldbe pushed distally through the advancement mechanism to make contactwith the IOL to completely deploy the IOL from the folded inserter.Because the IOL might be in a generally uncompressed state after theinserter has been pushed as far distally as possible, only a smallamount of additional force may be needed to completely push the IOL fromthe folded inserter. Therefore the plunger-like device would not damagethe IOL.

An alternative secondary advancement mechanism uses a hydraulic force tofully deploy the IOL from the folder inserter. A lumen within theadvancement mechanism can be used to deliver fluid within the inserterthereby forcing the IOL out of the inserter. Fluid will also minimizethe amount of shear or tensile forces acting on the IOL. A sealingmechanism such as a plug or other insert (such as a silicone material)can also be positioned into the rolled inserter to help create a sealbetween the IOL and the inserter to aid in the hydraulic ejection of theIOL.

In general the rolled inserter is a very thin material. In oneembodiment the rolled inserter comprises mylar and is about 0.004″thick. The cross section of the inserter may assume a variety ofcross-sectional shapes, such as round, oval, or elliptical.

FIGS. 18A-18E illustrate an embodiment of loading and delivery system300 for loading and delivering intraocular lens 310. The system includesrigid outer tube 302, flexible inner sleeve 304 (split into two halvesas shown), and compressor clips 306. Outer tube 302 is adapted to fitthrough about a 4 mm incision in the eye. Outer tube 302 is coupled toouter tube actuator 322 and inner sleeve 304 is coupled to inner sleeveactuator 324. The outer tube and inner sleeve can axially move withrespect to one another by actuation of one or both of outer sleeveactuator 322 and inner sleeve actuator 324. The compressor clips can belightly bonded (e.g., using a weak bonding material such as Loctite 495)or unbonded to the inner sleeve.

To load lens 310 into outer tube 302, the intraocular lens is firstpositioned in the system as shown in FIG. 18A (also shown in more detailin FIG. 18B). Haptics 312 are first positioned axially from opticportion 314 (one haptic leading and the other haptic trailing). Thisassists in the loading process. A compressive force in the generaldirection of arrows C is then applied to one or both of compressor clips306. The compressive force can be applied by a vise or other similardevice that brings two elements together to cause compressive force C tobe applied to the compressor clips. As a result, a compressive force isapplied to the lens and causes the lens to be compressed between the twohalves of the inner sleeve. The inner sleeves, and not the compressorclips, engage the lens. The compressive force is applied until the twohalves of the inner sleeve come together such that the lens is fullycompressed within the two halves of the inner sleeve. The compressorclips can be compressed until they engage with each other or there maybe a slight space between the edges of the compressor clips. During thecompression process the lens is compressed and elongated.

After the compressor clips are compressed to the closed (orsubstantially closed) position shown in FIG. 18C, outer tube actuator322 is advanced distally in the direction of arrow D (shown in FIG. 18D)and inner sleeve actuator 324 is held in place. The movement of outertube actuator 322 causes the outer sleeve to be advanced distally overthe inner sleeve (which is held in place). The inner sleeve could alsobe retracted proximally while the outer tube is held in place. Advancingthe outer tube displaces the compressor clips in the distal direction,which also move relative to the inner sleeve. The outer tube is advanceduntil the inner sleeve (and therefore the lens) is disposed within theouter tube, as shown in FIG. 18E. During this loading step slidingoccurs between the outer tube and the inner sleeve, not between the lensand the inner sleeve. This minimizes shear and tensile forces acting onthe lens.

The outer tube is then advanced through an incision made in the eye. Todeploy the lens from the delivery system and into the lens capsule,inner sleeve actuator 324 is advanced distally in direction D. Thiscauses inner sleeve to be advanced distally relative to the outer tube.As the inner sleeve emerges from the distal end of the outer tube, theinner sleeve will begin to split along the slit and the lens will beginto expand. The lens can therefore be delivered into the capsule.

The outer tube is generally rigid and in one embodiment is a stainlesssteel tube. The inner sleeve is generally a flexible material and in oneembodiment is PTFE. The compressor clips can be any suitably rigidmaterial.

Increasing the outer tube volume increases the volume into which thelens can be compressed. It is generally desirable for the outer tube tohave the largest cross sectional area possible while still allowing theouter tube to be advanced into the smallest incision possible. It hasbeen found than using an outer tube in which the cross section isgenerally elliptically-shaped allows the largest cross sectional areathrough the smallest incision.

In an alternative embodiment the inner sleeve as shown in FIGS. 18A-18Ecan be replaced with a rolled sheet such as inserter 64 shown in FIGS.15-17. The system would work similarly to the described above inreferences to FIG. 18A-18E.

FIGS. 19-21 show alternative embodiments of a hydraulic lens loadingsystem. Using a hydraulic system to load the intraocular lens into thedelivery device (as well as a hydraulic system to deploy the intraocularlens) minimizes shear and tensile forces on the lens. The lens is forcedinto a delivery device using a generally lubricous liquid or fluid,which minimizing shear and tensile forces acting on the lens as it iscompressed and elongated. FIG. 19 shows loading system 400 for loadingintraocular lens 402 into loading tube 408. The system includes syringe404 including plunger 406. Distal region 412 of syringe 404 includes atapered inner surface 410 which has a smaller cross sectional diameterat the distal end than at the proximal end. The distal region of thesyringe contains the lens as well as fluid 414. The fluid can be aliquid such as saline and can include or can be a known viscoelasticlubricant such as, for example without limitation, aqueous solutions ofsodium hyaluronate, hydroxypropylmethyl cellulose, and chondroitinsulfate.

To advance the lens into loading tube 408, the plunger is actuated inthe distal D direction which causes fluid 414 and lens 402 to beadvanced distally towards loading tube 108. The plunger continues to beadvanced distally until the lens is forced through proximal end 416 ofloading tube 108. By moving the lens with a lubricious material, shearand tensile forces on the lens are minimized.

FIG. 20 shows an alternative hydraulic loading system 600 for loadingintraocular lens 602 into loading tube 608. The system is similar toprevious embodiments and includes syringe 604 with plunger 606. Thesyringe includes lens chamber 612 which has a generally circular shapeto retain the generally circular shape of lens 602. The syringe alsoincludes tapered section 610 which directs the lens into loading tube608. Lens 602 is initially positioned in lens chamber 612 with distalhaptic 605 extending distally from optic portion 603 and into taperedsection 610 while proximal haptic 607 is not extending proximally fromoptic portion 603. This initial positioning helps direct the lens into acompressed configuration within loading tube 608 (which includesproximal end 616) when fluid 614 is forced through lens chamber 612. Theplunger is advanced distally to direct a fluid through lens chamber 612,which forces lens 602 into loading tube 608.

In an alternative design the intraocular lens can be loaded into theloading tube under vacuum pressure.

After the lens is loaded into the loading tube, the lens ishydraulically delivered into the eye. The loading tube is first detachedfrom the loading apparatus. The loading tube is then inserted through anincision in the eye and a fluid (such as a lubricious fluid) is directedthrough the loading tube to eject the lens from the loading tube andinto the eye. Hydraulic deployment also minimizes shear and tensileforces acting on the lens. A syringe can be used to direct the fluidthrough the loading tube. Alternatively, a small piston drives down thetube, pushing a short column of fluid distally to the piston. The pistonis controlled with an actuator such as a knob, lever, ratchet, etc. Thepiston can be attached to either end of the loading tube. This means thelens can be ejected from the same end in which it is loaded, or it canbe deployed from the other end of the loading tube.

FIG. 21 illustrates an alternative loading system concept usingperistaltic movement to load an intraocular lens (not shown). In thisdesign, purely compressive loads on the lens are separated in time fromshear loads on the lens. The lens is “inched” along into a fullycompressed state. System 700 includes rigid large tube 702, rigid smalltube 706, and flexible tube 704 with a generally conical or taperedshape. Fluid 710 is contained within the system to lubricate the systemand also to help push the lens through the system. The lens is movedfrom the rigid large tube 702 through flexible tube 704 and into a fullycompressed state within small rigid tube 706. Large tube 702 has alarger diameter than small tube 706. There is generally a pressuregradient between P1 and P2 with P1 being higher. The difference inpressure between P1 and P2 (which is the driving pressure) is equal toP1 minus P2. The pressure P3 from a compressive force on the flexibletube is used to compress the lens in a direction that is substantiallyorthogonal to the axis A. P3 is pulsed out of phase from the drivingpressure, which is also pulsed. To load the lens, P3 is initiallyincreased to compress the lens radially. Then P3 is decreased while thedriving pressure is increased, so the device is pushed in the directionD a small distance and reexpands radially. When P3 is decreased theflexible wall moves radially away from the lens and shear forces arereduced. P3 is then increased again, compressing the lens radially. P3is then decreased as the driving pressure is increased, which againmoved the lens in the direction D. The lens is therefore moved in smallincrements in the distal direction D, compressing it as it moves. Thismovement is repeated until the lens is fully compressed within smalltube 706. The lens can then be deployed using any of the methodsdescribed herein.

In any or all of the embodiments described herein, the method ofdelivery includes creating a wound in the eye which generally comprisesan incision in the eye. In some embodiments the incision is about 4 mmand preferably about 3.7 mm. The incision can, however, be slightlylarger or smaller.

In any of the embodiments described herein, the position and/ororientation of the IOL may need to be adjusted for the loading step. Forexample, when loading an IOL with haptics, it may be necessary to alignthe haptics so they are oriented generally along the longitudinal axisof the delivery device before compressing the lens (see, for example,FIG. 18B). Alternatively, only one haptic may be straightened while asecond haptic can be positioned peripherally around the optic portion(see, for example, FIG. 20). These orientations can provide for a betterdelivery profile and minimizes the chance of damage to the IOL duringdeployment.

To compress any of the fluid-filled accommodating IOL described herein,it may be necessary to apply a compressive side force of about 0.5pounds. This can vary, however, depending on the size, composition, andvolume of the IOL.

While only these embodiments have been described, they all attempt tominimize the amount of shear and tensile forces acting on the IOL duringthe loading and/or delivery process. One common method is minimizing theamount of sliding that occurs between the IOL and the delivery systemcomponents. Other embodiments are included in this invention which allowthe IOL to be loaded into and deployed from the delivery device with (orin conjunction with) a delivery device component, in order to reducethese unwanted forces.

1-27. (canceled)
 28. A method of loading an intraocular lens,comprising: providing an intraocular lens comprising an optic portion,and leading haptic and a trailing haptic; positioning the intraocularlens into an intraocular lens receiving area; deforming the leadinghaptic such that leading haptic is deformed from an at-restconfiguration and extends distally away from the optic portion while thetrailing haptic is not extending proximally from the optic portion; andloading the intraocular lens into a loading device.
 29. The method ofclaim 28, wherein loading comprises moving a plunger distally.
 30. Themethod of claim 28, wherein loading deforms the optic portion.
 31. Themethod of claim 28, wherein loading comprises advancing the opticportion through a tapered section.
 32. The method claim 28, whereinloading causes redistribution of a flowable material within theintraocular lens.